Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-151361 · Präparat HOS-100527
The frequency of dose interruption of nirogacestat due to adverse reactions was 59%. The most
common adverse reactions leading to dose interruption were diarrhoea (11%), rash maculo-
papular (10%), hypophosphatemia (6%) and nausea (5%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 9ef8fcf6bcf2668c68e041b2f2a37b55f9d0cecd686f0c497c569d4faa692feb · Zeichen 725–961 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-151362 · Präparat HOS-100527
The frequency of dose reduction of nirogacestat due to adverse reactions was 44%. The most common
adverse reactions leading to dose reduction were diarrhoea (9%), rash maculo-papular (6%),
stomatitis (3%), and hypophosphatemia (3%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage b33ece852c81483a1f15f55b7a550ff39b27245acee31745a9b353c6b3acf5de · Zeichen 963–1195 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-151363 · Präparat HOS-100527
Tabulated list of adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage d51c90b617391dca447a849e03c6ddac1785fb6a36da5cf3e36f8f60e5aed8a9 · Zeichen 1197–1232 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-151364 · Präparat HOS-100527
Unless otherwise stated, the frequencies of adverse reactions are based on all-cause adverse event
frequencies identified in 88 patients exposed to nirogacestat 150 mg twice daily during a median
duration of 21.5 months in clinical studies.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage acbedc3714d9f8e487361bd25e3a1175a8abdcfafad54de0ac0b723b25e15670 · Zeichen 1234–1474 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-151365 · Präparat HOS-100527
The adverse reactions are ranked under heading of frequency using the following convention: very
common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to
< 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 869468c667acb2411c210e6046d2eba0a98d7433a9641f5a0141c05183afdb6e · Zeichen 1476–1866 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-151366 · Präparat HOS-100527
Table 2: Adverse reactions reported
System organ class Adverse reaction All grades Grades 3-4
Gastrointestinal disorders Diarrhoea Very common Very common
Nausea Very common Common
Stomatitisa Very common Common
Dry mouth Very common --
Skin and subcutaneous Rashb Very common Common
disorders Alopecia Very common --
Folliculitis Very common Common
Hidradenitis Common Common
Dry skin Very common --
Pruritis Very common --
Neoplasms benign, malignant Basal cell carcinoma Common --
and unspecified Squamous cellc carcinoma Common --
Metabolism and nutrition Hypophosphataemia Very common Very common
disorders Hypokalaemia Very common Common
Nervous system disorders Headache Very common --
Dizziness Very common --
Investigation Proteinuria Very common --
Glycosuria Very common --
Blood and lymphatic system Eosinophilia Very common --
disorders
Renal and urinary disorders Renal tubular disorder Common --
Injury, poisoning and Bone fractured Common --
procedural complications
Hepatobiliary disorders ALT increased Very common Common
AST increased Very common Common
Reproductive system and Ovarian toxicitye Very common --
breast disorders
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage bb747fb61a142cca38fac7d979b72dbaa6887af75cae7977430ff5dcb7136cbd · Zeichen 1868–4216 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 9–10
HOS-151367 · Präparat HOS-100527
9
System organ class Adverse reaction All grades Grades 3-4
Respiratory, thoracic and Cough Very common --
mediastinal disorders Upper respiratory tract Very common --
infectionf
Dyspnoea Very common --
Epistaxis Very common --
General disorders and Fatigue Very common Common
administration site conditions Influenza-like illness Very common --
Eye disorders Photopsia Common --
Vitreous floaters Common --
Dry eye Common --
Immune system disorders Hypersensitivity* Not known
a
Stomatitis includes stomatitis, mouth ulceration, oral pain, and oropharyngeal pain.
b Rash includes rash maculo-papular, dermatitis acneiform, rash, rash erythematous, rash pruritic, and rash
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage f3f177139f18d5d9d17fbe8ea18f258b29b97514b4c9a7a600593b97bc98e520 · Zeichen 4271–5583 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151368 · Präparat HOS-100527
papular.
c Squamous cell carcinoma included squamous cell carcinoma of skin and squamous cell carcinoma.
d Bone fracture includes fracture, foot fracture, hand fracture, radius fracture, hip fracture and rib fracture.
e Ovarian toxicity includes ovarian failure, premature menopause, amenorrhoea, oligomenorrhoea, menstruation
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage c39d46340f4bacd066584e68249486aeeca159404c4b1957323bcc63e31f4e65 · Zeichen 5585–5911 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151369 · Präparat HOS-100527
irregular, dysmenorrhoea, heavy menstrual bleeding, vulvovaginal dryness, hot flush, decreased anti-Müllerian
hormone (AMH) and increased follicle-stimulating hormone (FSH).
f Upper respiratory tract infection (URTI) includes URTI, viral URTI, acute sinusitis, and sinusitis.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 3bd35a59c3bb0f29880e8483908af0eb0010d2660c3c8ddf2a089ef15fa39092 · Zeichen 5913–6188 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151370 · Präparat HOS-100527
-- Represents no cases were reported.
*
From post marketing cases.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 716fef834b7d906bcbe1cc749e5ffbc01aa1374134a22822ddb05f025520250f · Zeichen 6190–6258 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151371 · Präparat HOS-100527
Description of selected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 6260–6301 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151372 · Präparat HOS-100527
The data described below reflect results of the randomised, double-blind, Phase 3 DeFi study in
patients with desmoid tumours treated with 150 mg BID nirogacestat (N=69) or placebo (N=72) twice
daily.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage be66466fcf1d20ec42566620c10d0fe142cd78bcd8ab1ca260f133da607654d2 · Zeichen 6303–6503 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151373 · Präparat HOS-100527
Diarrhoea
In the double-blind phase of the DeFi study, diarrhoea was reported in 84% of patients receiving
nirogacestat compared to 35% in patients receiving placebo. Grade 3 events occurred in 16% and 1%
of patients, respectively (see section 4.4). Grade ≤ 2 diarrhoea resolved in 74% of patients who
continued on nirogacestat treatment. The median time to first onset of diarrhoea in patients receiving
nirogacestat was 9 days (range 2 to 434 days). Diarrhoea led to dose reduction in 10% of patients and
treatment discontinuation in 7% receiving nirogacestat.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 6a0673afc00e202795a1e28fc7c1e6c4d2c2982e042e1230dbc7747514fd859d · Zeichen 6505–7067 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151374 · Präparat HOS-100527
Skin and subcutaneous tissue disorders
In the double‑blind phase of the DeFi study, dermatologic reactions were reported at a higher
incidence in patients receiving nirogacestat than in those receiving placebo; they included
maculo‑papular rash (32% vs 6%), hidradenitis (9% vs 0), and folliculitis (13% vs 0) (see section 4.4).
The median time to rash events was 22 days (range 2 to 603 days). Skin and subcutaneous disorders
led to dose reduction in 9% of patients receiving nirogacestat, including maculo‑papular rash in 4%
and hidradenitis in 3%. Maculo‑papular rash led to treatment discontinuation in 1%.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage e8b55949f08b324071c8ad1c1cabbac4263dfd2b65bd534a1348e6fc9e4cf8b4 · Zeichen 7069–7679 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-151375 · Präparat HOS-100527
Ovarian toxicity
In the double‑blind phase of the DeFi study, 75% of women of childbearing potential receiving
nirogacestat reported ovarian toxicity (defined as ovarian failure, premature menopause, amenorrhoea,
oligomenorrhea, and menopause) compared to no patients receiving placebo. There were three serious
adverse reactions of ovarian toxicity, all premature menopause, representing 11% of all participants
reporting ovarian toxicity. The median time to first onset of ovarian toxicity was 8.9 weeks (range
1 day to 54 weeks), and the overall median duration was 18.9 weeks (range 11 days to 215 weeks).
Ovarian toxicity has been reported to resolve in 79% of women of childbearing potential during
treatment. Follow up information is available for all but two out of 27 patients; after stopping
treatment, ovarian toxicity was reported to resolve in all women of childbearing potential for whom
data are available. The median time to resolution after discontinuing nirogacestat was 10.9 weeks
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 346b88ec70bab079bf263c5163760be40245d741b8d05f4cce94f2e002de5a7b · Zeichen 7681–8680 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 10–11
HOS-151376 · Präparat HOS-100527
10
(range 4 to 18 weeks). Effects of nirogacestat on fertility are unknown (see section 4.4). An exposure-
response relationship was identified between nirogacestat and serum follicular stimulating hormone
(FSH) levels, with FSH increasing linearly with increasing serum concentrations of nirogacestat.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 84a91d8f92a8eee4a3f9b981af8e6e15852d6c91d0d1ad6d7cd285d83701c242 · Zeichen 8740–9043 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-151377 · Präparat HOS-100527
Electrolyte abnormalities
Electrolyte abnormalities were reported in patients receiving nirogacestat in the double‑blind phase of
the DeFi study, including hypophosphataemia (43%) and hypokalaemia (12%), compared to 7% and
1%, respectively, in patients receiving placebo. Median time to first onset of hypophosphataemia and
hypokalaemia was 15 days (range 1 to 833 days) and 15 days (range 1 to 57 days), respectively.
Grade 3 events of hypophosphataemia and hypokalaemia occurred in 3% of patients receiving
nirogacestat compared to no patients receiving placebo (see section 4.4). Hypophosphataemia and
hypokalaemia led to dose reduction in 4% and 1% of patients receiving nirogacestat, respectively.
Hypophosphataemia led to dose discontinuation in 1% of patients receiving nirogacestat.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 10aaada83101a5942ce6bb28e0a403eb06178907610266d848da502f9f32aa64 · Zeichen 9045–9835 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-151378 · Präparat HOS-100527
Hepatic abnormalities
ALT and AST elevations were reported in 19% and 17%, respectively, of patients receiving
nirogacestat in the double‑blind phase of the DeFi study compared to 8% and 11%, respectively, in
patients receiving placebo. Median time to first onset of ALT and AST elevations was 22 days (ALT
range 8 to 924 days; AST range 1 to 1023 days). Grade 3 ALT and AST elevations (> 5 x ULN)
occurred in 3% of patients treated with nirogacestat compared to 1% in the placebo arm (see
section 4.4). ALT and AST elevations each led to dose reduction in 1% of patients receiving
nirogacestat. ALT and AST elevations led to dose discontinuation in 4% and 3% of patients receiving
nirogacestat, respectively.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage e3b72f8f3ec2b38d7b29f513eadfc6c0c2136b694deb362ad847fb362e9ea893 · Zeichen 9837–10546 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-151379 · Präparat HOS-100527
Non-melanoma skin cancers
Non-melanoma skin cancers were reported at a higher incidence in patients receiving nirogacestat than
in those receiving placebo in the double‑blind phase of the DeFi study, including squamous cell
carcinoma (3% vs 0) and basal cell carcinoma (1% vs 0), with one patient reporting both types of
non‑melanoma skin cancer (see section 4.4). An additional two cases of non‑melanoma skin cancer
were reported outside of the double‑blind phase of the DeFi study.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage ae0cde247f9edbe4258e4d552ecd7964f277e553337338c09dfd471aaec1f3e8 · Zeichen 10548–11031 im Abschnitt
Nebenwirkungen · Ogsiveo
Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-151380 · Präparat HOS-100527
Proximal renal tubule effect
Glycosuria and proteinuria were observed in 52% and 46%, respectively, of patients receiving
nirogacestat in the double‑blind phase of the DeFi study, compared with 1% and 39%, respectively, in
patients receiving placebo. Median time to onset of glycosuria and proteinuria was 85 days (range 55
to 600 days) and 72 days (range 38 to 937 days), respectively. One patient in the DeFi study reported
renal tubular disorder with increased urinary excretion of uric acid, glucose and phosphate, but no
excess excretion of low molecular weight proteins (beta2‑microglobulin) or any change in renal
function. The event was managed with dose reduction.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-02T10:08:54Z · SHA-256 a10b40c69711900f14e5e9a8780be46aa9e05f46c98543243cf1f3336a270e67 · Passage 8c93001593dfb42f0f34844d73e4158771d6f7cd75a002a80335cc059dbf8657 · Zeichen 11033–11706 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.